Technical Manager – Validation Services
Technical Manager - Validation Science
(US) Wilmington, Mt Vernon, (UK) Macclesfield (Sweden) Gartuna
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The Technical Manager Validationposition resides in the Manufacturing Science & Technology Organisation within the Product Robustness Centre of Excellence (CoE). This position is part of a team responsible for defining and driving the standards & practices for ensuring end to end commercial product robustness across all small molecule dosage form types. One of the key areas to ensure success of product robustness is validation. The Product Robustness CoE is also responsible for providing direct statistical product support including validation approaches across the product lifecycle in line with current regulatory expectations.
The Manufacturing Science and Technology function resides within the PT&D (Pharmaceutical Technology & Development) Organization in the Operations SET area. The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. The On Market Technical Functions provide the expert technical support for AstraZeneca commercial products. MS&T provides technical support in 3 key areas 1) Direct to product technical support for all commercial products in the areas of chemistry, manufacturing and control 2) Science & Technology Strategy and Process Engineering and 3) Driving Product Robustness.
Under pinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. The On Market technical functions are a strong network of scientists located across the world at our key manufacturing, development sites and strategic hubs. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.
- In this role, you will be responsible for the expert delivery of technical standards and guidance for drug product validation approaches within AstraZeneca Global Operations. You will identify and deliver risk based simplification strategies to validation methodology.
- You will support the standardization of validation approaches at Operations sites globally and support the management of product control strategies and quality risk assessment in the post approval phase as it relates to validation sciences.
- Providing validation expertise and knowledge to aid the resolution of potential product recall incidents and major incidents as required. Maintaining your expert knowledge as it relates to regulations and guidance documents including statistical justification for validation approaches.
- You will be responsible for the project management of strategic initiatives including, securing sponsorship, resource requirements, stakeholder management and tracking timing and benefits for new Validation guidelines or methods.
- Take ownership of the Continued Process Verification approaches across AstraZeneca and drive the implementation of process intelligence tools and reporting mechanisms across the network.
- The role requires you to work collaboratively with the Validation forum, Global Quality, Development Units, Operations sites and Global Engineering to provide science based solutions to Process and Cleaning validation activities. You will also work collaboratively with analytical sciences for method and validation cleaning approaches and with statisticians in defining approaches to ensure robust validation outcomes.
- Strong validation background with experience of equipment, process (PPQ), cleaning and method validation in the Pharmaceutical industry
- Educated to degree or equivalent experience in Pharmaceutical Sciences or Engineering
- Understand the application of CQAs, CMAs and CPPs to validation approaches and sampling plans
- Experienced in commercial technical drug product support
- Experience in Pharmaceutical Operations and /or R&D with a track record of successful project leadership and project delivery in a matrix organization.
- Excellent communication and stakeholder management skills
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.